The Recall Desk
SevereFDA (Devices)·Z-2259-2017·Announced 2017-06-14

Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

Arrow International is recalling 43,394 units of MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a Class II medical device with reported needlestick injuries, which aligns with the rubric criterion for 'significant injury reports' and the requirement that Class II recalls with injury reports be scored as Severe.

Plain-English summary

Arrow International Inc. has initiated a nationwide recall of 43,394 units of the MAC Two-Lumen Central Venous Access Kit with ARROWg+ard Blue Access Device. The affected product is identified by Material Number ASK-21142-HF2. This medical device is used for venous access and catheter introduction into the central circulation via the jugular, subclavian, or femoral veins.

The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with certain Arrow products. The source text does not specify the number of reported injuries or the specific dates of the incidents.

Healthcare facilities and consumers should stop using the affected kits immediately. Arrow International is the recalling firm responsible for managing this Class II recall.

The recalled product

Product
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) p
Affected units
43,394

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Material Number ASK-21142-HF2

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →